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Enteric Fever | Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever

Enteric Fever research study

What is the primary objective of this study?

The investigators aim to compare two antibiotic treatments for enteric (typhoid) fever. Three hundred patients at Patan Hospital will be enrolled in the study. Patients will be assigned to one of the two treatments by chance and followed for 6 months. The two treatment groups will be compared to see which treatment is more likely to make the patient better.

Who is eligible to participate?

Inclusion Criteria: - Suspected or culture proven enteric fever - >= 2 <= 45 years of age - Fever >= 38°C for >= 4 days - Informed consent to participate in the study Exclusion Criteria: - Pregnancy - Obtundation - Shock - Visible jaundice - Presence of signs of gastrointestinal bleeding - Evidence of severe disease - Diabetes - History of hypersensitivity to either of the trial drugs - Known previous treatment with a quinolone antibiotic or 3rd generation cephalosporin or macrolide within one week of hospital admission.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Enteric Fever

Typhoid Fever

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Ceftriaxone≥2-<14 years - 60mg/kg/ once daily for 7 days 14 years and older - 2g once daily for 7 days Intravenous infusion. Vials of crystalline powder.

Drug:GatifloxacinGatifloxacin 10 mg/kg/day for 7 days. Tablets for oral administration.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

GatifloxacinGatifloxacin 10mg/kg/day for 7 days

Ceftriaxone≥2-<14 years - 60mg/kg/ once daily for 7 days 14 years and older - 2g once daily for 7 days

Study Status

Completed

Start Date: September 2011

Completed Date: January 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Rate of treatment failure

Secondary Outcome: S.typhi or S.paratyphi carriage

Study sponsors, principal investigator, and references

Principal Investigator: Buddha Basnyat, MD

Lead Sponsor: Oxford University Clinical Research Unit, Vietnam

Collaborator: University of Oxford

More information:https://clinicaltrials.gov/show/NCT01421693

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